NCT05696145尚未招募不适用
Aortic Stenosis Associated Left Ventricular Remodeling - Impact of Genetic, Valvular and Non-valvular Factors
Lisa Gundestrup0 个研究点目标入组 170 人开始时间: 2023年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 主要终点
- Genetic polymorphisms betweem low flow low gradient and high flow high gradient aortic stenosis patients
研究概览
简要总结
The goal of this study is to investigate the genetic and gender specific differences, in patients with low flow low gradient aortic stenosis and high flow high gradient aortic stenosis. Patients referred for surgical aorticvalve replacement will be offered to participarte in the study.
The main questions the study aims to answer are:
- Low-gradient aortic stenosis is associated with differences in valvular concentration of the genes that code for mast-cell chymase, Angiotensin-II, ACE, ACE2 and Angiotensin receptor 1 and 2.
- Low-gradient aortic stenosis is associated with differences in the genetic code of renin-angiotensin-aldosterone system.
- Gender differences in LV remodelling associates with different levels of sexual hormones.
Patients participating in the study will be asked to undergo:
- Cardiac ultrasound, MR- and CT-scan prior to surgery
- Blooddraw prior to surgery.
- Heartmuscle biopsy during surgery
- Cardiac MR-scan 1 year after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe AS (estimated by the local heart team, aortic valve area<1cm2) referred for AVR at the cardiology department at Odense University Hospital
- •Age > 18 years
- •Signed informed consent
排除标准
- •Bicuspid aortic valve.
- •LV systolic dysfunction (LVEF<50%).
- •Patients with concomitant moderate-severe aortic valve regurgitation.
- •Concomitant moderate-severe mitral valve regurgitation.
- •Moderate to severe nephropathy (s-creatinine >200 mmol/l)
- •Unwilling to participate in the study.
- •Claustrophobia.
- •Permanent cardiac devices (pacemaker and ICD)
结局指标
主要结局
Genetic polymorphisms betweem low flow low gradient and high flow high gradient aortic stenosis patients
时间窗: At the time of surgery
次要结局
未报告次要终点
研究者
Lisa Gundestrup
MD.
Odense University Hospital
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